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FDA Expedited Approvals of Expanded Cord Blood Products

As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.

Date

Expanded
Cord Blood
Product

Manufacturer

Indication

FDA Expedited Path(s)

20180717

NiCord®

Gamida Cell

HSCT: Hematopoietic
Stem Cell Transplants

Breakthrough Therapy
Orphan Drug

20180806

NLA101
Dilanubicel

Nohla Therapeutics

HSCT engraftment,
Neutropenia

Orphan Drug
Fast Track

20180823

Pneumostem®

Medipost

Bronchopulmonary Dysplasia

Orphan Drug
Fast Track

20190423

ECT-001

ExCellThera

Hematologic
Malignancies

Regenerative Medicine Advanced Therapy (RMAT)

20190904

MGTA-456

Magenta
Therapeutics

Inherited Metabolic Disorders

Regenerative Medicine Advanced Therapy (RMAT)